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B. Braun Medical Ltd.'s Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions


3/21/2008 10:47:59 AM

Scientific Protein Laboratories LLC (SPL) manufactures Heparin Sodium USP active pharmaceutical ingredient that is used by B. Braun Medical Inc. to produce Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride injection solutions

IRVINE, Calif.--(BUSINESS WIRE)--B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects the following 23 Finished Product (FP) lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.

B. Braun FP Lot #

B. Braun FP Material Description NDC Numbers CAN DIN J7D490 P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A J7C684 P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A J7D496 P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A J7C470 P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A J7D580 P5671-00

Heparin Sodium 20,000 Units in 5% Dextrose Injection (500mL) N/A 02209713 J7E420 P5872-00

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) N/A 02209721 J7C611 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933 J7C557 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933 J7C477 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933 J7C705 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933 J7D485 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10 01935933 J7E415 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933 J7E416 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933 J7E494 P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A J7E500 P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A J7E577 P5771-00

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) N/A 01935941 J7E489 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933 J7N556 P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A J7P404 P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A J7N604 P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A J7P476 P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A J7N519 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933 J7N676 P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933

B. Braun Medical Inc. began recalling the lots on March 21, 2008 as a precautionary measure. This product recall was initiated due to a notification received from the supplier, Scientific Protein Laboratories (SPL), disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient acquired by B. Braun Medical Inc. has a heparin-like contaminant. To date, B. Braun Medical Inc. has not received any adverse event reports related to this issue.

The Food and Drug Administration has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

Adverse reactions or quality problems experienced in the U.S. with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

* Online: www.fda.gov/medwatch/report.htm * Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 * Fax: 1-800-FDA-0178

Adverse reactions or quality problems experienced in Canada with use of this product may be reported to Health Canada. For details on how to report these reactions please refer to the following website:

* Online: www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index_e.html

Customers who have product in their possession from the recalled product lots should discontinue use immediately. Patients reporting any problems that may be related to the use of this product should be advised to contact a physician. Customers may contact B. Braun Medical Inc. Customer Support Department at (800) 227-2862 for U.S. and (800) 624-2920 for Canada, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product. Contacts

Media: Stern + Associates for B. Braun Medical Inc. Stephanie Euler, 908-276-4344 ext. 213 stephanie@sternassociates.com or Corporate: B. Braun Medical Inc. Susan Denby, 610-997-4856 susan.denby@bbraun.com or Customer Support: United States: 800-227-2862 Canada: 800-624-2920



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